CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE

BRIEFING INFORMATION

October 15, 1999

BLA #97-200

Medical Officer's Review

Cover and Table of Contents

1.0 The EPILOG Trial -- Review of the EPILOG Study Report 

2.0 Risk Status Assessment in the EPILOG Trial--Response to FDA Information Request

3.0 Review of the Independent Angiogram Re-Review Study Report 

4.0 Review of the Aniographic Substudy of the EPILOG Trial

5.0 Clinical Review of the Readministration Study

BLA #93-1051 & 93-1057

Review of ReoPro